Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Formoterol fumarate dihydrate
Drug ID BADD_D00960
Description Formoterol is an inhaled beta2-agonist used in the management of COPD and asthma that was first approved for use in the United States in 2001.[L10986] It acts on bronchial smooth muscle to dilate and relax airways, and is administered as a racemic mixture of its active (R;R)- and inactive (S;S)-enantiomers.[A189528] A major clinical advantage of formoterol over other inhaled beta-agonists is its rapid onset of action (2-3 minutes), which is at least as fast as [salbutamol], combined with a long duration of action (12 hours) - for this reason, treatment guidelines for asthma recommend its use as both a reliever and maintenance medication.[L11256] It is available as a single-entity product[L10986,L11223] and in several formulations in combination with both inhaled corticosteroids[L10995,L10619] and long-acting muscarinic antagonists.[L10992,L10989]
Indications and Usage For use as long-term maintenance treatment of asthma in patients 6 years of age and older with reversible obstructive airways disease, including patients with symptoms of nocturnal asthma, who are using optimal corticosteroid treatment and experiencing regular or frequent breakthrough symptoms requiring use of a short-acting bronchodilator. Not indicated for asthma that can be successfully managed with occasional use of an inhaled, short-acting beta2-adrenergic agonist. Also used for the prevention of exercise-induced bronchospasm, as well as long-term treatment of bronchospasm associated with COPD.
Marketing Status Prescription; Discontinued
ATC Code R03AC13; R03CC15
DrugBank ID DB00983
KEGG ID D05277
MeSH ID D000068759
PubChem ID 60196271
TTD Drug ID D04KJO
NDC Product Code 49076-7001; 65015-771; 64567-0006; 53183-7544; 49502-605; 63190-0450; 63190-0360; 0378-1631; 51927-0216; 43898-0130; 51927-4925; 43898-0131; 82245-0113
Synonyms Formoterol Fumarate | Formoterol Fumarate, ((R*,R*)-(+-))-isomer | 3-Formylamino-4-hydroxy-alpha-(N-1-methyl-2-p-methoxyphenethylaminomethyl)benzyl alcohol.hemifumarate | BD 40A | Formoterol | Eformoterol | Oxis | Arformoterol | Formoterol, ((R*,R*)-(+-))-isomer | Foradil
Chemical Information
Molecular Formula C42H56N4O14
CAS Registry Number 183814-30-4
SMILES CC(CC1=CC=C(C=C1)OC)NCC(C2=CC(=C(C=C2)O)NC=O)O.CC(CC1=CC=C(C=C1)OC)NCC(C2=CC(=C( C=C2)O)NC=O)O.C(=CC(=O)O)C(=O)O.O.O
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Eosinophilic disordersInterleukin-5P05113T78585Not Available
Eosinophilic disordersC-X-C motif chemokine 10P02778T30635Not Available
Surgical and medical proceduresBeta-2 adrenergic receptorP07550T52522Not Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Angina pectoris24.04.04.002; 02.02.02.002--
Arrhythmia02.03.02.001--Not Available
Diarrhoea07.02.01.001--
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Dry mouth07.06.01.002--
Fatigue08.01.01.002--
Headache17.14.01.001--
Hyperglycaemia14.06.02.002; 05.06.02.002--
Hypertension24.08.02.001--
Hypokalaemia14.05.03.002--
Hypotension24.06.03.002--
Insomnia19.02.01.002; 17.15.03.002--
Malaise08.01.01.003--
Metabolic acidosis14.01.01.003--Not Available
Muscle spasms15.05.03.004--
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Nervousness19.06.02.003--Not Available
Palpitations02.01.02.003--
Tachycardia02.03.02.007--Not Available
Tremor17.01.06.002--
Vomiting07.01.07.003--
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